Iowa CLIA Laboratory Program
State Hygienic Laboratory
UI Research Park
2490 Crosspark Road
Coralville, IA 52241-4721
phone 800.421.IOWA or 319.335.4500
Kristine Rotzoll, BS, MT(ASCP)
CLIA Compliance Manager
Melinda Bochmann, BA, MT(AMT)
CLIA Compliance Specialist
Do you need to stay current with the Federal CLIA laboratory requirements? Does your laboratory have the tools to provide quality testing for its clients and patients? The Hygienic Lab's CLIA Corner can help. To subscribe, email one of the CLIA Compliance professionals listed above.
In 1988, Congress passed the Clinical Laboratory Improvement Amendments (CLIA), establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.
The federal law states any laboratory or facility that performs laboratory testing of human specimens for the purpose of providing information for the diagnosis, prevention or treatment of disease or impairment of, or the assessment of the health of, human beings is required to obtain a CLIA certificate and to meet certain requirements.
This rule applies whether or not the facility bills Medicare, Medicaid, other insurance, the patient, or provides the service for no charge. The type of CLIA certificate a laboratory must have depends on the type of testing the laboratory performs.
How is the Hygienic Lab involved?
The State Hygienic Laboratory is under contract with the Iowa Department of Inspections and Appeals and the Centers for Medicare & Medicaid Services to oversee the CLIA Laboratory Program for the State of Iowa. The Hygienic Laboratory administers the program and provides laboratory surveyors to conduct clinical laboratory inspections. Iowa does not have additional State licensure or certification requirements for laboratories.
How does a lab apply for CLIA certification?
Complete the Application for Certification (form CMS-116) and submit it to the appropriate State Agency. Laboratories within Iowa may submit the appplication to Hygienic Lab. Laboratories outside Iowa should contact the CLIA State Agency for the state in which they are located. Refer to the Centers for Medicare and Medicaid Services for more information.